title: Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: a randomized study.
abstract: OBJECTIVE
  Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura.
  
  
  METHODS
  Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium ( N  = 222 intent-to-treat (ITT)) or placebo ( N  = 221 ITT/complete case analysis (a) ) in this randomized, double-blind, parallel-group study.
  
  
  RESULTS
  Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, P  < 0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, P  < 0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose ( P  < 0.001), pain-free response maintained one to two hours postdose ( P  = 0.034) and two to four hours postdose ( P  < 0.001), headache relief four hours postdose ( P  < 0.001), headache relief maintained two to four hours postdose ( P  = 0.015), sustained headache relief two through 24 hours postdose ( P  = 0.002), and rescue medication use ( P  < 0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo).
  
  
  CONCLUSIONS
  Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.
authors.affiliation: Jefferson Headache Center, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Silberstein
authors.forename: Susan A
authors.initials: SA
authors.lastname: McDonald
authors.forename: Jerome
authors.initials: J
authors.lastname: Goldstein
authors.forename: Sheena
authors.initials: S
authors.lastname: Aurora
authors.forename: Shelly E
authors.initials: SE
authors.lastname: Lener
authors.forename: Jonathan
authors.initials: J
authors.lastname: White
authors.forename: Michael C
authors.initials: MC
authors.lastname: Runken
authors.forename: Jane
authors.initials: J
authors.lastname: Saiers
authors.forename: Frederick
authors.initials: F
authors.lastname: Derosier
authors.forename: Richard B
authors.initials: RB
authors.lastname: Lipton
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020326:Migraine without Aura / Q000188:drug therapy*; D009288:Naproxen / Q000627:therapeutic use*; D018170:Sumatriptan / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D009288:Naproxen; D018170:Sumatriptan
keywords: Migraine; clinical trial; headache; probable migraine; sumatriptan/naproxen sodium